Biomarker Qualification Submissions

The table below lists information about submissions to the FDA biomarker qualification program for which final biomarker qualification decisions have not yet been made. This table includes legacy projects (those submitted prior to passage of the 21st Century Cures Act, Section 3011 legislation [Food, Drug and Cosmetic Act (FD&CA), new section 507 process or “section 507 process”]) as well as those submitted as part of the 507 process. This table is updated on a biannual basis and provides information on the biomarker qualification project, FDA’s decision to Accept or Not Accept the submission, and FDA’s recommendations on further biomarker development.

*Information submitted to FDA by outside parties requesting qualification of a drug development tool is not endorsed or recommended by FDA. Submissions are made publicly available in accordance with the 21st Century Cures Act. The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.

Joint Qualification Committee of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Radiologic Society of North America (RSNA) Quantitative Imaging Biomarker Alliance (QIBA)

The safety biomarker for preclinically identifying the pro-arrhythmia risk of drugs, with specific focus on Torsade de Pointes (TdP) type arrhythmias

The Pro-Arrhythmia Score will be used at the preclinical stage of drug discovery to assess the TdP pro-arrhythmia risk of a test article, in order to facilitate clinical development and risk management planning, and support benefit-risk analysis, as well as enable regulatory decision making.

Prognostic enrichment imaging biomarker panel for use in phase 2 and 3 clinical trials to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression within the subsequent 48 months based on the WOMAC pain subscale and/or radiographic joint space width loss and/or joint replacement.

Prognostic enrichment molecular biomarkers for use in phase 2 and 3 clinical trials to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression within the subsequent 48 months based on the WOMAC pain subscale and/or radiographic joint space width loss and/or joint replacement.